DoubleDex Kit

Product NDC
76420-766
11-digit product format
764200766
Labeler code
76420
Product ID
76420-766_47db098f-6da3-2339-e063-6294a90a4c84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate, Povidine Iodine
Dosage form
KIT
Route
INTRAMUSCULAR; INTRAVENOUS; TOPICAL
Labeler
Asclemed USA, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-07-25
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
DoubleDex Kit
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
797730Internal RxNorm lookup
1812079Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b7d58d9b-e1fa-4a7f-afca-beb06d028057Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-766-01DoubleDex Kit1 in 1 CARTONKIT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-766-01EA - Each76420-7660ac6d968-e96e-45c2-abb1-cd7206b4c26a12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dexamethasone Sodium PhosphateACTIVE INGREDIENTAI9376Y64PDOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Isopropyl AlcoholACTIVE INGREDIENTND2M416302DOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Povidone-IodineACTIVE INGREDIENT85H0HZU99MDOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
DexamethasoneACTIVE MOIETY7S5I7G3JQLDOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
IodineACTIVE MOIETY9679TC07X4DOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Isopropyl AlcoholACTIVE MOIETYND2M416302DOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPDOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Nonoxynol-9INACTIVE INGREDIENT48Q180SH9TDOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRDOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RDOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-766DOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]8Current NDC, Legacy NDC, 1 package rows20241008_b7d58d9b-e1fa-4a7f-afca-beb06d028057.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoubleDex KitDEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINEAsclemed USA, Inc.b7d58d9b-e1fa-4a7f-afca-beb06d0280572026-01-08Warnings, Adverse reactionsExact identifier
ndc (product): 76420-766

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812079dexAMETHasone sodium phosphate 10 MG in 1 ML InjectionPSNb7d58d9b-e1fa-4a7f-afca-beb06d0280579
797544isopropyl alcohol 70 % Medicated PadPSNb7d58d9b-e1fa-4a7f-afca-beb06d0280579
797730povidone-iodine 10 % Medicated PadPSNb7d58d9b-e1fa-4a7f-afca-beb06d0280579
18120791 ML dexamethasone phosphate 10 MG/ML InjectionSCDb7d58d9b-e1fa-4a7f-afca-beb06d0280579
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDb7d58d9b-e1fa-4a7f-afca-beb06d0280579
797730povidone-iodine 100 MG/ML Medicated PadSCDb7d58d9b-e1fa-4a7f-afca-beb06d0280579
1812079dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML InjectionSYb7d58d9b-e1fa-4a7f-afca-beb06d0280579
797544isopropyl alcohol 70 % Medicated PadSYb7d58d9b-e1fa-4a7f-afca-beb06d0280579
797544isopropyl alcohol 70 % Topical ClothSYb7d58d9b-e1fa-4a7f-afca-beb06d0280579
797544isopropyl alcohol 70 % Topical SwabSYb7d58d9b-e1fa-4a7f-afca-beb06d0280579
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYb7d58d9b-e1fa-4a7f-afca-beb06d0280579
797730povidone-iodine 10 % Medicated PadSYb7d58d9b-e1fa-4a7f-afca-beb06d0280579
797730povidone-iodine 10 % Medicated SwabstickSYb7d58d9b-e1fa-4a7f-afca-beb06d0280579
1812079dexAMETHasone sodium phosphate 10 MG in 1 ML InjectionPSNfb85dd2c-6c90-6249-e053-6294a90a09fa2
797544isopropyl alcohol 70 % Medicated PadPSNfb85dd2c-6c90-6249-e053-6294a90a09fa2
797730povidone-iodine 10 % Medicated PadPSNfb85dd2c-6c90-6249-e053-6294a90a09fa2
18120791 ML dexamethasone phosphate 10 MG/ML InjectionSCDfb85dd2c-6c90-6249-e053-6294a90a09fa2
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDfb85dd2c-6c90-6249-e053-6294a90a09fa2
797730povidone-iodine 100 MG/ML Medicated PadSCDfb85dd2c-6c90-6249-e053-6294a90a09fa2
1812079dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML InjectionSYfb85dd2c-6c90-6249-e053-6294a90a09fa2
797544isopropyl alcohol 70 % Medicated PadSYfb85dd2c-6c90-6249-e053-6294a90a09fa2
797544isopropyl alcohol 70 % Topical ClothSYfb85dd2c-6c90-6249-e053-6294a90a09fa2
797544isopropyl alcohol 70 % Topical SwabSYfb85dd2c-6c90-6249-e053-6294a90a09fa2
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYfb85dd2c-6c90-6249-e053-6294a90a09fa2
797730povidone-iodine 10 % Medicated PadSYfb85dd2c-6c90-6249-e053-6294a90a09fa2
797730povidone-iodine 10 % Medicated SwabstickSYfb85dd2c-6c90-6249-e053-6294a90a09fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-766-01764200766011 KIT in 1 CARTON (76420-766-01) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL1 kit2016-05-230000-00-00NoNoCurrent